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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05075707
Other study ID # magnetic and laser therapy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2021
Est. completion date February 23, 2022

Study information

Verified date March 2022
Source Delta University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trigeminal neuralgia (TN) was defined by The International Association for the Study of Pain (IASP) as severe, sudden, usually unilateral, stabbing, brief, recurrent attacks of pain in one or more distributional branches of the trigeminal nerve. The purpose of the current study will to investigate the effect of Low level laser therapy versus electromagnetic therapy on diabetic trigeminal neuralgia pain intensity and amplitude of the compound muscle action potential of the masseter and temporalis muscles in diabetic TN patients.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 23, 2022
Est. primary completion date February 22, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - All participants will between the ages of 25 and 45, will of both sexes (male and female), diabetic type two patients with chronic trigeminal neuralgia, (from three to six months). - Patients will awake, cooperative, and free of psychiatric issues (as determined by a psychologist) as well as difficulties resulting from orthopaedic or special sensory deficits. Exclusion Criteria: - Patients will ruled out if they developed TN due to a tumour, herpes zoster, or any other reason other than diabetes, such as significant coagulation dysfunction, cardiopulmonary dysfunction or previous invasive treatment (ethanol, radiofrequency, Gama-knife microvascular decompression, glycerinum injection). - They will not have a previous disability in the face.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electromagnetic therapy.
Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.
Low level laser therapy (LLLT)
Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention.

Locations

Country Name City State
Egypt AAA Cairo

Sponsors (1)

Lead Sponsor Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Studies using electromyography and complex muscle action potentials All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated before interventions. at the beginning of the study
Primary Studies using electromyography and complex muscle action potentials All patients' compound motor action potential amplitudes in the masseter and temporalis muscles will be evaluated after two month of interventions. by the end of successful two month of intervention
Primary Visual analogue scale (VAS) All the participants were instructed to express their pain by Visual analogue scale (VAS) before the interventions. at the beginning of the study
Primary Visual analogue scale (VAS) All the participants were instructed to express their pain by Visual analogue scale (VAS) after two month of interventions. by the end of successful two month of intervention
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